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Mar 31, 2021
TG Therapeutics Q1 2021 Earnings Report
TG Therapeutics reported first quarter 2021 financial results and provided a business update.
Key Takeaways
TG Therapeutics reported product revenue of $0.8 million for the first quarter of 2021, driven by the launch of UKONIQ. The company's R&D expenses increased to $63.1 million, and SG&A expenses rose to $26.8 million, reflecting commercial launch activities. Net loss for the quarter was $90.6 million. The company's cash, cash equivalents and investment securities were $523.8 million as of March 31, 2021.
Received accelerated approval for UKONIQ from the FDA on February 5, 2021, and launched it for relapsed or refractory MZL and FL.
Completed a BLA submission for ublituximab in combination with UKONIQ (U2) to treat patients with CLL.
Presented positive results from the ULTIMATE I & II Phase 3 trials in relapsing forms of MS.
Cash, cash equivalents and investment securities were $523.8 million as of March 31, 2021, expected to fund operations into 2023.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics is focused on commercializing UKONIQ, submitting a BLA for ublituximab in RMS, receiving notification from the FDA for U2 in CLL, enrolling in the ULTRA-V Phase 3 trial, and advancing early pipeline candidates.
Positive Outlook
- Focus on the commercialization of UKONIQ in relapsed/refractory MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 for CLL and ublituximab in MS
- Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021, based on positive results from the ULTIMATE I & II Phase 3 trials
- Receive notification from the FDA that the BLA for U2 in CLL has been accepted for filing and work closely with the Agency on its review of the application
- Enroll into the newly launched ULTRA-V Phase 3 trial evaluating the triple combination of U2 plus venetoclax
- Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801